Huahai Pharmaceutical's Class 1 New Drug, IL-17 Monoclonal Antibody HB0017, Granted Clinical Trial Approval in China for Moderate-to-Severe Plaque Psoriasis

Reposted from: Medical Perspective

According to public information from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, HB0017 injection, jointly submitted by Huabo Biopharm and Huaota Biopharm—subsidiaries of Huahai Pharmaceutical—has received implicit approval for clinical trials. The indicated condition is moderate-to-severe plaque psoriasis. HB0017 is a monoclonal antibody targeting IL-17, classified as a Class 1 novel drug, marking its first clinical trial approval in China. IL-17 is one of the prominent therapeutic targets that has spurred the development of multiple blockbuster innovative drugs.

IL-17, short for Interleukin-17, was discovered by scientists in the 1990s. Subsequent research has demonstrated that IL-17 is a key pro-inflammatory cytokine that plays a critical role in the pathogenesis of various autoimmune diseases, including psoriasis, psoriatic arthritis, and ankylosing spondylitis. Based on these significant findings, IL-17 has emerged as an important therapeutic target for such conditions, leading to the development of several blockbuster innovative drugs.

HB0017 is a monoclonal antibody targeting IL-17, developed by Huahai Pharmaceutical for the treatment of psoriasis, psoriatic arthritis, and ankylosing spondylitis. In April 2020, the drug received approval from the U.S. FDA to conduct investigational new drug clinical trials.

This marks the first approval of HB0017 for clinical trials in China, targeting moderate-to-severe plaque psoriasis. However, information on the CDE website indicates that a subsidiary of Huahai Pharmaceutical has already submitted three investigational new drug (IND) applications for HB0017 injection, suggesting that the drug is also poised to gain approval for clinical studies targeting other indications in the future.

Currently, multiple drugs targeting IL-17 have been approved and launched globally, including Novartis’s IL-17A monoclonal antibody Cosentyx (secukinumab), Eli Lilly and Company’s IL-17A antagonist Taltz (ixekizumab), and Valeant Pharmaceuticals’ IL-17A receptor-targeting monoclonal antibody Siliq (brodalumab). According to the financial reports of these companies, the global sales of secukinumab in 2019 amounted to USD 3.551 billion, while those of ixekizumab reached USD 1.37 billion.

In China, currently only two IL-17 targeted drugs have been approved for marketing: one is Novartis’ Cosentyx, which has been approved for two indications—adult patients with moderate-to-severe plaque psoriasis and adult patients with ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy; the other is Eli Lilly’s ixekizumab, which was first approved last September for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Congratulations to Huahai Pharmaceutical on the approval of its IL-17 monoclonal antibody HB0017 for clinical trials. We hope that the research on this drug proceeds smoothly, providing more treatment options for patients.

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